High-intensity laser therapy (class IV) and ibuprofen gel phonophoresis for treating knee osteoarthritis among people living in hilly terrain: a randomized, double blind, multi-centre trial protocol

INTRODUCTION: People living in hilly terrain with abnormal cyclic loading could lead to bone cartilage degeneration. High-intensity laser therapy (HILT) and Ibuprofen gel phonophoresis (IGP) have innumerable benefits for patients with knee osteoarthritis (KOA). However, it is still unclear which treatment is effective among them in rehabilitating patients with KOA. OBJECTIVE: To verify whether 8-week HILT is no worse than the IGP in treating patients with knee osteoarthritis living in hilly terrain. MATERIALS AND METHODS: A total of 108 individuals with KOA will be recruited by simple random sampling to participate in a randomized, double-blind, controlled study. Recruited individuals with KOA will be randomly divided into two groups, the HILT group (experimental group) and the IGP group (active control group). The treatment duration of HILT and IGP will be 8 minutes in one session/knee joint for each day for 3 days/week up to 8 weeks in addition to their conventional exercises for 30 minutes. The Western Ontario and McMaster Universities Osteoarthritis Index, Digitalized pain pressure algometer, and 36-Item Short-Form Health Survey questionnaire are the outcome measures that will be recorded at baseline, end of the 8-week post-intervention period. PERSPECTIVES: The results from this trial will contribute to evidence-based recommendations for the clinical implication of whether HILT is no worse than IGP, along with exercise intervention for treating individuals with KOA living in hilly terrain. Trial Registry: Clinical Trials Registry (NCT04320914)